CompletedNot Applicable

A Novel Bi-dimensional Archwire for Miniscrew-supported En-masse Retraction

Syria6 participantsStarted 2025-07-01

Plain-language summary

This study aims to provide a preliminary clinical evaluation of a novel bi-dimensional archwire used during miniscrew-supported en-masse retraction of the maxillary anterior teeth. Adult patients with Class II Division 1 malocclusion requiring extraction of the maxillary first premolars will be screened at the Department of Orthodontics, Faculty of Dentistry, Damascus University. Eligible participants will receive fixed orthodontic treatment followed by en-masse retraction using a custom-made laser-welded bi-dimensional stainless-steel archwire consisting of a 0.019 × 0.025-inch anterior segment and 0.016 × 0.022-inch posterior segments. Retraction will be supported by orthodontic miniscrews and nickel-titanium closed-coil springs. The main outcome will be the monthly rate of maxillary anterior retraction assessed on three-dimensional digital dental models. A secondary outcome will be the change in maxillary incisor torque assessed on lateral cephalometric radiographs. This pilot study is intended to generate preliminary clinical data regarding the feasibility and performance of this novel archwire design.

Who can participate

Age range

18 Years – 28 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults aged 18-28 years with skeletal Class II malocclusion (ANB angle 5°-7°) * Class II Division 1 dental malocclusion according to Angle classification * An average or vertical facial growth pattern * A treatment plan requiring extraction of the maxillary first premolars * A need for maxillary anterior en-masse retraction * The presence of all permanent maxillary teeth except the third molars Exclusion Criteria: * Patients with previous orthodontic treatment, * Craniofacial anomalies, systemic diseases affecting bone metabolism * Active periodontal disease * Poor oral hygiene * Missing maxillary permanent teeth, or were using * The use of medications known to influence bone metabolism

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in the monthly rate of maxillary anterior en-masse retraction

Timeframe: Time 0: completion of leveling and alignment which happens within three months); Times 1, 2, 3, 4, 5 after one, two, three, four, and five months following the end of the leveling and alignment stage; Time Final: at the end of the retraction stage.

Trial details

NCT IDNCT07664215

SponsorDamascus University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-27

View on ClinicalTrials.gov More Malocclusion Class II trials